Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults

NCT ID: NCT05602506

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-06-05

Brief Summary

This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.

Detailed Description

The Primary objectives are:

1. To assess viral efficacy of the reductions of BETAF regimen dose at 12 weeks (on-treatment and intent-to-treat populations).

2. To asess viral efficacy of the reduction of BETAF regimen dose at 48 weeks (on-treatment and intent-to-treat populations).

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BETAF OD arm

one tablet taken orally once daily

Group Type: ACTIVE_COMPARATOR

Biktarvy 50 mg/200 mg/25 mg film-coated tablets

Intervention Type: DRUG

The duration of the study treatment will be 48 weeks.

BETAF 3W arm

one tablet taken orally 3 days per week : Mondays, Wednesdays, and Fridays

Group Type: EXPERIMENTAL

Biktarvy 50 mg/200 mg/25 mg film-coated tablets

Intervention Type: DRUG

The duration of the study treatment will be 48 weeks.

BETAF 2W arm

one tablet taken orally 2 days per week : Mondays, and Thursdays

Group Type: EXPERIMENTAL

Biktarvy 50 mg/200 mg/25 mg film-coated tablets

Intervention Type: DRUG

The duration of the study treatment will be 48 weeks.

BETAF 1W arm

one tablet taken orally 1 days per week : Mondays

Group Type: EXPERIMENTAL

Biktarvy 50 mg/200 mg/25 mg film-coated tablets

Intervention Type: DRUG

The duration of the study treatment will be 48 weeks.

Interventions

Biktarvy 50 mg/200 mg/25 mg film-coated tablets

The duration of the study treatment will be 48 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Stable and asymptomatic HIV-infected adults (≥18 years) on BETAF once daily for at least the previous 6 months.
• Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months.
• CD4 cell counts greater than 350 cells/mL at the time of consideration for the study.
• Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods.
• Patients agreed to participate.

Exclusion Criteria

• Prior virological failure to any antiretroviral regimen or documented.
• Any diagnosis of psychiatric illness.
• Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment).
• Patients co-infected with HIV and active hepatitis B or C virus.
• Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Anna Cruceta

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clinic i Provincial Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

BETAF-RED

Identifier Type: -

Identifier Source: org_study_id